Tocilizumab plus standard therapy for chronic antibody-mediated rejection after kidney transplant

Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab

This trial will try adding tocilizumab to standard treatment (plasmapheresis, IVIG, and rituximab) to see if it helps people with chronic active antibody-mediated rejection of a kidney transplant.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shahid Beheshti University of Medical Sciences (Academic / other)
• Drugs / interventions: rituximab, Tocilizumab
• Locations: 1 site (Tehran)
• Trial ID: NCT07006532 on ClinicalTrials.gov

What this trial studies

This open-label randomized trial tests whether adding the IL-6 blocker tocilizumab to standard care (plasmapheresis, IVIG, and rituximab) is safe and more effective for treating chronic active antibody-mediated rejection (CAMR) in kidney transplant recipients. Eligible participants meet biopsy and lab criteria (eGFR >25 mL/min, chronicity index <8, IFTA <40%, EBV IgG positive) and are randomized to receive standard therapy with or without tocilizumab. The study will track donor-specific antibody levels, graft function, and adverse events to determine safety and benefit. The trial is conducted at a single center in Tehran and is open-label.

Who should consider this trial

Good fit: Ideal candidates are kidney transplant recipients with biopsy-proven chronic active antibody-mediated rejection who have eGFR >25 mL/min, chronicity index <8, IFTA <40%, and are EBV IgG positive.

Not a fit: Patients with active or recurrent infections, abnormal liver function tests, low platelets (<100,000), recent or active malignancy, or very low kidney function (eGFR ≤25 mL/min) are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, adding tocilizumab could lower donor-specific antibody levels and improve kidney graft survival in patients with CAMR.

How similar studies have performed: Some small case series and early trials of tocilizumab in antibody-mediated rejection have shown mixed signals for reducing donor-specific antibodies or stabilizing graft function, and other approaches like plasmapheresis, IVIG, rituximab, and bortezomib have produced inconsistent results in CAMR.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent
2. eGFR\> 25 cc/min
3. Chronicity index \<8
4. IFTA\<40%
5. EBV IgG positive

Exclusion Criteria:

1. Active or recurrent infections
2. History of malignancy, unless in remission for more than 2 years with no relapse
3. abnormal liver function tests
4. Platelet \< 100,000

Where this trial is running

Tehran

• Nooshin Dalili — Tehran, Iran (Recruiting)

Study contacts

• Study coordinator: Pi

Conditions Kidney Transplant Rejection